Trial Outcomes & Findings for Syncope Decision Aid for Emergency Care (NCT NCT02971163)
NCT ID: NCT02971163
Last Updated: 2020-05-26
Results Overview
Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.
COMPLETED
NA
50 participants
Two years
2020-05-26
Participant Flow
After screening 351 patients, 51 randomized, one was excluded because not syncope, resulting in 50 participants enrolled with unexplained syncope from January 2017 to January 2019.
Participant milestones
| Measure |
SynDA
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
SynDA
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Syncope Decision Aid for Emergency Care
Baseline characteristics by cohort
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=99 Participants
|
60 years
n=107 Participants
|
58.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Control Preferences Scale
1
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Control Preferences Scale
2
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Control Preferences Scale
3
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Control Preferences Scale
4
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Control Preferences Scale
5
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Control Preferences Scale
Missing data
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Subjective Numeracy Score (SNS)
|
13.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Short Literacy Survey (SLS)
|
13.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Education
Some High School
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education
High School Graduate/GED
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Some College
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Education
College Graduate
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Graduate School
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Income
Less than $20,000
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Income
$20,000 to $29,999
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
$30,000 to $39,999
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Income
$40,000 to $59,999
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
$60,000 to $79,999
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Income
$80,000 to $99,999
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Income
$100,000 or more
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Income
Rather Not Say
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Canadian Syncope Risk Score
Low: 0 (≈2% risk)
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Canadian Syncope Risk Score
Medium: 1 (≈3% risk)
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Canadian Syncope Risk Score
Medium: 2 (≈5% risk)
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two yearsFeasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Number of Participants at End of Study
|
20 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Within 2 hours post ED disposition on Day 1One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Patient Knowledge
|
5.2 score on a scale
Standard Deviation 1.8
|
5.3 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Within 2 hours post ED disposition on Day 1Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Decisional Conflict Scale
|
8.9 score on a scale
Standard Deviation 1.5
|
9 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Day 1 and 30 day follow up periodNumber of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Utilization Outcomes
Admitted to hospital Day 1
|
0 Participants
|
0 Participants
|
|
Utilization Outcomes
Sent to observation unit Day 1
|
4 Participants
|
7 Participants
|
|
Utilization Outcomes
Admitted to hospital 30 day follow up period
|
1 Participants
|
1 Participants
|
|
Utilization Outcomes
Office visit 30 day follow up period
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 30-day follow-up periodNumber of participants with repeat visits to the ED during 30-day follow-up period
Outcome measures
| Measure |
SynDA
n=20 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=24 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Number of Participants With Repeat Visits to the ED
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at 30 daysNumber of participants with clinical diagnosis at 30 days after index visit to the ED
Outcome measures
| Measure |
SynDA
n=20 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=24 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Participants With New Significant Clinical Diagnosis
Acute Stroke
|
1 Participants
|
0 Participants
|
|
Participants With New Significant Clinical Diagnosis
Heart Failure
|
1 Participants
|
0 Participants
|
|
Participants With New Significant Clinical Diagnosis
Cardiac Arrhythmia
|
0 Participants
|
1 Participants
|
|
Participants With New Significant Clinical Diagnosis
Large Pericardial Effusion
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
Number of Diagnostic Testing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsThe degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.
Outcome measures
| Measure |
SynDA
n=24 Participants
The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
|
Control
n=26 Participants
Patients in the control arm will receive usual emergency care pertaining to syncope.
|
|---|---|---|
|
OPTION-5 Scale
|
52.0 score on a scale
Standard Deviation 18
|
26.6 score on a scale
Standard Deviation 21
|
Adverse Events
SynDA
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place